1. Field of the Invention
The present invention relates generally to medical procedures and, more specifically, to system and apparatus for performing endoscopic procedures for internal organs, including stomach, colon, mouth, hypopharynx, larynx, duodenum, small intestine, urinary bladder, urethra, chest cavity, bronchioles, trachea, peritoneal cavity, middle ear. In this particular invention a standardized method is developed to prepare the area of interest, by using special lights, dyes, or any other technology, that will enhance the visibility of abnormalities, and thus increase early detection of disease. Also the test is standardized using a coordinate system either analog or digital that can increase reproducibility of the exam, and once digitalized can be transmitted to a remote place to allow for tele-medicine operations. In addition a new medical endoscopy nomenclature describe every part/portion located within a specific organ.
The application illustrates a specific embodiment of the invention, which is not intended to limit the invention in any manner.
2. Description of the Prior Art
There are other endoscopic diagnostic methods known in the art. While these techniques may be suitable for the purposes for which they where designed, they would not be as suitable for the purposes of the present invention as heretofore described.
Standard esophago/gastro/duodenoscopy (SEG) examines the upper gastrointestinal GI (hypopharynx, esophagus, stomach and duodenum). Colonoscopy examines the rectum, colon, terminal ileum. In spite of massive worldwide use of SEG and standard colonoscopy, gastric and esophageal and colorectal cancers are still leading causes of death in many countries. In the USA, gastric cancer accounts for about 7500 new cases each year, while colon cancer is the third cancer in frequency in both men and women. Colon cancer is a much more severe problem in the USA than gastric cancer. Multiple tests are available as options for CRC screening. While stool-based tests improve disease prognosis by detecting early stage treatable cancers (and possibly advanced adenomas), endoscopic or radiologic tests that visualize the gastrointestinal mucosa have the potential to also prevent cancer by detecting polyps that can be endoscopically removed prior to malignant transformation. Thus, endoscopy is superior to radiologic techniques since it is both diagnostic and therapeutic.
In both colon and gastric cancer (in most cases) patients have a long “preclinical phase” meaning the disease is present, but unless early detected through endoscopy with a biopsy of the site (which can be extremely hard to see and locate), the disease is undetectable. At this stage, there are no clinical manifestations, meaning the patient does not feel anything. This phase can last for years, and as such there is a great need to detect the disease and treat it at the earliest possible stage.
In regards to the upper GI tract, SEG reports usually diagnosis either two disease conditions: chronic gastritis (a benign inflammation of the stomach) or an advanced stage tumor mass (where no cure is possible). It is noteworthy that endoscopic diagnosis of early cancer lesions is extremely low in many countries, including the U.S. The reasons for this are twofold: massive screening like in Japan and one recently in Colombia do not exist in the U.S.; and the lack of a standardized medical procedure to examine the organs so all the organs' surfaces are seen and recorded (via photography, video or both), which allows for early detection and treatment. Some lesions can look very benign and early cancer can be very difficult to diagnose: small tumors can look like tiny mucosal depressions, discoloration of the mucosa or slight elevations of the surface and therefore are frequently misdiagnosed as benign disease states.
There is presently enough technology to re-design the way examination of the GI tract is done utilizing the present invention described here and all the existing technology to detect disease much earlier allowing the introduction and reinforcement of the concept of cure to GI tract malignancies. These present invention as described herein incorporates these changes.
Most authorities would agree that as of today, the “gold standard” for upper GI examination is standard SEG, and for colonic diseases is standard colonoscopy. Some trials have investigated the use of “virtual colonoscopy” (CT scan) but colonoscopy is currently considered the state of the art diagnostic tool. Current upper or lower endoscopies have several limitations, including high operator dependence. This translates into higher cost and fewer “operators” available at any given time, thus posing a significant limitation to mass screening campaigns, as illustrated in FIG. 12 which shows how the present invention will lower operator dependence and increase the number of individuals which can be screened via Systematic Chromoendoscopy (SCE) and Systematic Chromocolonoscopy (SCC).
Another limitation is the lack of standardization: no particular protocol is followed, no particular order is followed, and the information seen is generally not recorded permanently. This poses a huge problem, for example, a lesion that is not visible to one operator may be visible to other and vice versa. Localization of lesions is sometimes hard. Virtual colonoscopy has some standardization, such as a permanent record of the exam (the CT pictures) with each picture corresponding to an anatomical location. The present invention, however, introduces standardization to the manner in which endoscopic GI exams are performed.
Furthermore, the preparation for screening exams is not optimal. Despite the proven benefit of using dyes and special lights the current screenings are rarely done using these available technologies.
The above-described issues represent huge obstacles to early detection and mass screening initiatives, and allow for the loss of many lives, by losing the opportunity to catch the disease in the preclinical phase. As many countries, including the U.S., face the challenges of an aging population and the looming possibility of medical doctor shortages, the current healthcare delivery structure needs to change. The present invention implements technology that can allow for this transition, allowing better efforts towards prevention of preventable widespread metastatic cancer, from a localized tumor in the stomach or colon, or other areas/organs that could be accessible in the future by endoscopic instruments.